Vaccine Information: Pfizer-BioNTech Covid-19 Vaccine, Bivalent (Page 7 of 13)

14.2 Efficacy of 2-Dose Primary Series of Pfizer-BioNTech COVID-19 Vaccine (Original Monovalent) in Participants 12 Through 15 Years of Age

A descriptive efficacy analysis of Study 2 has been performed in approximately 2,200 participants 12 through 15 years of age evaluating confirmed COVID-19 cases accrued up to a data cutoff date of March 13, 2021.

The efficacy information in participants 12 through 15 years of age is presented in Table 16.

Table 16: Vaccine Efficacy – First COVID-19 Occurrence From 7 Days After Dose 2: Without Evidence of Infection and With or Without Evidence of Infection Prior to 7 Days After Dose 2 – Blinded Placebo-Controlled Follow-up Period, Participants 12 Through 15 Years of Age Evaluable Efficacy (7 Days) Population
Note: Confirmed cases were determined by Reverse Transcription-Polymerase Chain Reaction (RT-PCR) and at least 1 symptom consistent with COVID-19 (symptoms included: fever; new or increased cough; new or increased shortness of breath; chills; new or increased muscle pain; new loss of taste or smell; sore throat; diarrhea; vomiting).
*
Participants who had no evidence of past SARS-CoV-2 infection (i.e., N-binding antibody [serum] negative at Visit 1 and SARS-CoV-2 not detected by NAAT [nasal swab] at Visits 1 and 2), and had negative NAAT (nasal swab) at any unscheduled visit prior to 7 days after Dose 2 were included in the analysis.
†
Pfizer-BioNTech COVID-19 Vaccine (Original monovalent, 30 mcg modRNA).
‡
N = Number of participants in the specified group.
§
n1 = Number of participants meeting the endpoint definition.
Total surveillance time in 1000 person-years for the given endpoint across all participants within each group at risk for the endpoint. Time period for COVID-19 case accrual is from 7 days after Dose 2 to the end of the surveillance period.
#
n2 = Number of participants at risk for the endpoint.
Þ
Confidence interval (CI) for vaccine efficacy is derived based on the Clopper and Pearson method adjusted for surveillance time.

First COVID-19 occurrence from 7 days after Dose 2 in participants 12 through 15 years of age without evidence of prior SARS-CoV-2 infection *

Pfizer-BioNTech COVID-19 Vaccine † N ‡ =1005 Cases n1 § Surveillance Time (n2 # )

Placebo N ‡ =978 Cases n1 § Surveillance Time (n2 # )

Vaccine Efficacy % (95% CI Þ )

Participants 12 through 15 years of age

00.154 (1001)

160.147 (972)

100.0(75.3, 100.0)

First COVID-19 occurrence from 7 days after Dose 2 in participants 12 through 15 years of age with or without evidence of prior SARS-CoV-2 infection

Pfizer-BioNTech COVID-19 Vaccine † N ‡ =1119 Cases n1 § Surveillance Time (n2 # )

Placebo N ‡ =1110 Cases n1 § Surveillance Time (n2 # )

Vaccine Efficacy % (95% CI Þ )

Participants 12 through 15 years of age

00.170 (1109)

180.163 (1094)

100.0(78.1, 100.0)

14.3 Efficacy of 2-Dose Primary Series of Pfizer-BioNTech COVID-19 Vaccine (Original Monovalent) in Participants 5 Through 11 Years of Age

A descriptive efficacy analysis of Study 3 has been performed in 1,968 participants 5 through 11 years of age without evidence of infection prior to 7 days after Dose 2. This analysis evaluated confirmed symptomatic COVID-19 cases accrued up to a data cutoff date of October 8, 2021.

Table 17 presents the specific demographic characteristics in participants who did not have evidence of prior infection with SARS-CoV-2 through 7 days after the second dose.

Table 17: Demographics Characteristics – Participants Without Evidence of Infection Prior to 7 Days After Dose 2 – Phase 2/3 – 5 Through 11 Years of Age – Evaluable Efficacy Population
Pfizer-BioNTech COVID-19 Vaccine * 10 mcg/Dose (N † =1305) n ‡ (%) Placebo (N † =663) n ‡ (%)
*
Pfizer-BioNTech COVID-19 Vaccine (Original monovalent, 10 mcg modRNA).
†
N = number of participants in the specified group from the evaluable efficacy population with no evidence of SARS-CoV-2 infection prior to 7 days after Dose 2. This value is the denominator for the percentage calculations. Evaluable efficacy population included all eligible randomized participants who received all vaccination(s) as randomized within the predefined window, had no other important protocol deviations as determined by the clinician.
‡
n = Number of participants with the specified characteristic.
§
Includes multi-racial and not reported.
Number of participants who have 1 or more comorbidities that increase the risk of severe COVID-19 disease: defined as participants who had at least 1 of the prespecified comorbidities based on MMWR 69(32);1081–1088 and/or obesity (BMI ≥ 95th percentile).

Sex

Male

679 (52.0)

343 (51.7)

Female

626 (48.0)

320 (48.3)

Age at Vaccination

Mean (SD)

8.2 (1.93)

8.1 (1.98)

Median

8.0

8.0

Min, max

(5, 11)

(5, 11)

Race

White

1018 (78.0)

514 (77.5)

Black or African American

76 (5.8)

48 (7.2)

American Indian or Alaska Native

<1.0%

<1.0%

Asian

86 (6.6)

46 (6.9)

Native Hawaiian or other Pacific Islander

<1.0%

<1.0%

Other §

110 (8.4)

52 (7.8)

Ethnicity

Hispanic or Latino

243 (18.6)

130 (19.6)

Not Hispanic or Latino

1059 (81.1)

533 (80.4)

Not reported

<1.0%

<1.0%

Comorbidities

Yes

262 (20.1)

133 (20.1)

No

1043 (79.9)

530 (79.9)

The descriptive vaccine efficacy results in participants 5 through 11 years of age without evidence of prior SARS-CoV-2 infection are presented in Table 18. None of the cases accrued met criteria for severe COVID-19 or multisystem inflammatory syndrome in children (MIS-C). No cases of COVID-19 were observed in either the vaccine group or the placebo group in participants with evidence of prior SARS-CoV-2 infection.

Table 18: Vaccine Efficacy – First COVID-19 Occurrence From 7 Days After Dose 2: Without Evidence of Infection Prior to 7 Days After Dose 2 – Phase 2/3 – Participants 5 Through 11 Years of Age Evaluable Efficacy Population
First COVID-19 occurrence from 7 days after Dose 2 in participants 5 through 11 years of age without evidence of prior SARS-CoV-2 infection *
Pfizer-BioNTech COVID-19 Vaccine † 10 mcg/dose N ‡ =1305 Cases n1 § Surveillance Time (n2 # ) Placebo N ‡ =663 Cases n1 § Surveillance Time (n2 # ) Vaccine Efficacy % (95% CI)
Note: Confirmed cases were determined by Reverse Transcription-Polymerase Chain Reaction (RT-PCR) and at least 1 symptom consistent with COVID-19 (symptoms included: fever; new or increased cough; new or increased shortness of breath; chills; new or increased muscle pain; new loss of taste or smell; sore throat; diarrhea; vomiting).
*
Participants who had no evidence of past SARS-CoV-2 infection (i.e., N-binding antibody [serum] negative at Visit 1 and SARS-CoV-2 not detected by NAAT [nasal swab] at Visits 1 and 2), and had negative NAAT (nasal swab) at any unscheduled visit prior to 7 days after Dose 2 were included in the analysis.
†
Pfizer-BioNTech COVID-19 Vaccine (Original monovalent, 10 mcg modRNA).
‡
N = Number of participants in the specified group.
§
n1 = Number of participants meeting the endpoint definition.
Total surveillance time in 1000 person-years for the given endpoint across all participants within each group at risk for the endpoint. Time period for COVID-19 case accrual is from 7 days after Dose 2 to the end of the surveillance period.
#
n2 = Number of participants at risk for the endpoint.

Participants 5 through 11 years of age

30.322 (1273)

160.159 (637)

90.7(67.7, 98.3)

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